FDA DevicesClass III
Philips S4-1 Ultrasound Transducer
Published: April 1, 2026Recall ID: Z-1625-2026Category: devicesCountry: US
Reason for Recall / Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product Description & Identification
Philips S4-1 Ultrasound Transducer
Additional Source Details
| Field | Value |
|---|---|
| City | Reedsville |
| State | PA |
| Event id | 97643 |
| Address 1 | 1 Echo Dr |
| Code info | Model No. 989605458221, 989605458222, 989605477101; UDI: (01)00884838085183(21)B25VV3, (01)00884838085183(21)B21XVK, (01)00884838085183(21)B1ZJVG, (01)00884838085183(21)B2D31R, (01)00884838085183(21)B21XXK, (01)00884838085183(21)B25VX0, (01)00884838085183(21)B21Y07, (01)00884838085183(21)B21Y6L, (01)00884838085183(21)B21XYW, (01)00884838085183(21)B1RCNL, (01)00884838074231(21)B21Y64, (01)00884838074231(21)B21YF6, (01)00884838085183(21)B2D34Z, (01)00884838085183(21)B1RCVN, (01)00884838085183(21)B1W8DH, (01)00884838085183(21)B21XTP, (01)00884838085183(21)B21XXQ, (01)00884838085183(21)B25VWD, (01)00884838085183(21)B2Y9PD, (01)00884838085183(21)B2Y9W3, (01)00884838085183(21)B1RCZK, (01)00884838086579(21)B2C76J, (01)00884838085183(21)B2D30D, (01)00884838085183(21)B2792J, (01)00884838085183(21)B2D36X, (01)00884838085183(21)B278QM, (01)00884838085183(21)B21Y7X, (01)00884838085183(21)B1ZJVN, (01)00884838085183(21)B1RCRC, (01)00884838074231(21)B1RCWC, (01)00884838074231(21)B1RCQL, (01)008848380... [TRUNCATED] |
| Postal code | 17084-8603 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 41 units |
| Reason for recall | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250905 |
| Initial firm notification | Letter |
| Center classification date | 20260324 |
Overview
- Recalling FirmPhilips Ultrasound, Inc
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide distribution.